Catalog Number

-

Brand Name

Synchrony Face & Neck PENS Electrode

Version/Model Number

74921

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

bab27618-cf4e-4a13-a1e0-54ebe5ebb16f

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

August 16, 2016

Package DI Number

10858703006198

Quantity per Package

10

Contains DI Package

00858703006191

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-